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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. ToothWave™ is intended for over-the-counter use.
HOME SKINOVATIONS LTD
ToothWave US
In Commercial Distribution

  • 07290112451675 ()
  • 17290112451672 ()
  • 27290112451679 ()
7290112451675

  • Radio-frequency toothbrush
The Silk'n Titan Allways is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n Titan Allways is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The Silk'n Titan AllWays device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
HOME SKINOVATIONS LTD
Titan AllWays
In Commercial Distribution

  • 17290112451559 ()
  • 07290112451552 ()
7290112451552

  • Radio-frequency skin surface treatment system
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
HOME SKINOVATIONS LTD
Flash & Go LUXX Mini-Spa
In Commercial Distribution

  • 27290112450559 ()
  • 17290112450552 ()
  • 07290112450555 ()
7290112450555

  • Cosmetic red-light phototherapy system, home-use
The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles.
HOME SKINOVATIONS LTD
BellaVisage
In Commercial Distribution

  • 17290112450224 ()
  • 07290112450227 ()
  • 27290112450221 ()
7290112450227

  • Radio-frequency skin surface treatment system
No Description
HOME SKINOVATIONS LTD
Tightra NA
In Commercial Distribution

  • 07290112450067 ()
  • 17290112450064 ()
  • 37290112450068 ()
  • 27290112450061 ()
7290112450067

  • Penile sexual vibrator
An over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
HOME SKINOVATIONS LTD
Renelif
In Commercial Distribution

  • 07290106259218 ()
  • 27290106259212 ()
  • 17290106259215 ()
7290106259218

  • Cosmetic red-light phototherapy system, home-use
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth.
SILKN BEAUTY LTD
Silk'n 7
In Commercial Distribution

  • 27290019840255 ()
  • 17290019840258 ()
  • 07290019840251 ()
7290019840251

  • Cosmetic red-light phototherapy system, home-use
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth.
SILKN BEAUTY LTD
Silk'n 7
In Commercial Distribution

  • 27290019840248 ()
  • 17290019840241 ()
  • 07290019840244 ()
7290019840244

  • Cosmetic red-light phototherapy system, home-use
The device is a face treatment device which utilizes Home Technology™. The device combines several kinds of energy: Low Level Laser Therapy (LLLT), Infrared and Bi-Polar Radio Frequency energy (Bi-Polar RF) that treat the upper layer, dermis and deep sub-dermal fat to improve the skin's appearance and reduce wrinkles. The device includes a treatment surface with 3 electrodes and a control button with 5 surrounding indicator lights. The device is provided with an RF Attachment which provides larger treatment surface. It has a rechargeable battery for cordless use, as well as a wall adapter for connection to the mains supply.
SILKN BEAUTY LTD
Titan MultiPlatform
In Commercial Distribution

  • 27290019840231 ()
  • 17290019840234 ()
  • 07290019840237 ()
7290019840237

  • Radio-frequency skin surface treatment system applicator
The device is a face treatment device which utilizes Home Technology™. The device combines several kinds of energy: Low Level Laser Therapy (LLLT), Infrared, and Bi-Polar Radio Frequency energy (Bi-Polar RF) that treat the upper layer, dermis and deep sub-dermal fat to improve the skin's appearance and reduce wrinkles. The device has a treatment surface with 3 electrodes and a control button with 5 surrounding indicator lights. The device has a rechargeable battery and is for cordless use only. A wall adapter is supplied to charge the device.
SILKN BEAUTY LTD
Titan Mini
In Commercial Distribution

  • 27290019840224 ()
  • 17290019840227 ()
  • 07290019840220 ()
7290019840220

  • Radio-frequency skin surface treatment system applicator
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